Microwave ablation system with user-controlled ablation size and method of use

ABSTRACT

Disclosed is a system and method for enabling user preview and control of the size and shape of an electromagnetic energy field used in a surgical procedure. The disclosed system includes a selectively activatable source of microwave surgical energy in the range of about 900 mHz to about 5 gHz in operable communication with a graphical user interface and a database. The database is populated with data corresponding to the various surgical probes, such as microwave ablation antenna probes, that may include a probe identifier, the probe diameter, operational frequency of the probe, ablation length of the probe, ablation diameter of the probe, a temporal coefficient, a shape metric, and the like. The probe data is graphically presented on the graphical user interface where the surgeon may interactively view and select an appropriate surgical probe. Three-dimensional views of the probe(s) may be presented allowing the surgeon to interactively rotate the displayed image.

BACKGROUND

The present application is a continuation of U.S. patent applicationSer. No. 15/055,009, filed on Feb. 26, 2016, now U.S. Pat. No.10,111,718, which is a continuation of U.S. patent application Ser. No.14/036,006, filed on Sep. 25, 2013, now U.S. Pat. No. 9,867,670, whichis a continuation of U.S. patent application Ser. No. 12/416,583, filedon Apr. 1, 2009, now U.S. Pat. No. 9,277,969. The entire disclosures ofall of the foregoing applications are incorporated by reference herein.

1. Technical Field

The present disclosure relates to systems and methods for providingenergy to biological tissue and, more particularly, to systems andmethods for enabling user selection of the size and shape of a microwaveenergy field used in a surgical procedure.

2. Background of Related Art

Energy-based tissue treatment is well known in the art. Various types ofenergy (e.g., electrical, ultrasonic, microwave, cryogenic, thermal,laser, etc.) are applied to tissue to achieve a desired result.Electrosurgery involves application of high radio frequency electricalcurrent to a surgical site to cut, ablate, coagulate or seal tissue. Inmonopolar electrosurgery, a source or active electrode delivers radiofrequency energy from the electrosurgical generator to the tissue and areturn electrode carries the current back to the generator. In monopolarelectrosurgery, the source electrode is typically part of the surgicalinstrument held by the surgeon and applied to the tissue to be treated.A patient return electrode is placed remotely from the active electrodeto carry the current back to the generator. In tissue ablationelectrosurgery, the radio frequency energy may be delivered to targetedtissue by an antenna or probe.

In the case of tissue ablation, a high radio frequency energy in therange of about 300 mHz to about 300 gHz is applied to a targeted tissuesite to create an ablation volume, which may have a particular size andshape. The particular type of tissue ablation procedure may dictate aparticular ablation volume in order to achieve the desired surgicaloutcome. By way of example, and without limitation, a spinal ablationprocedure may call for a longer, more narrow ablation volume, whereas ina prostate ablation procedure, a more spherical ablation volume may berequired.

The ablation volume may be affected by various factors, includingwithout limitation, probe construction, antenna size and shape,frequency, energy level, energy delivery method, and duration of energydelivery. Conventionally, a surgeon must rely upon professionalexperience and published specifications to select an ablation probe andrelated electrosurgical parameters with which to achieve a desiredablation volume for a particular patient.

SUMMARY

The present disclosure provides an electromagnetic surgical ablationsystem having a generator assembly that includes generator module thatis configured to provide radiofrequency surgical energy, such aselectrosurgical or microwave energy. A processor is included in thegenerator assembly that is operably coupled to the generator module anda user interface. The user interface may include a graphic touchscreendisplay, as well as switches and illuminated indicators. The userinterface displays a graphical representation of a surgical instrument,such as without limitation a microwave antenna probe. The graphicalrepresentation includes an image corresponding to the instrument'sradiating field, such as without limitation an antenna probe ablationpattern. The disclosed system includes a database in operablecommunication with the processor that is adapted to store probeparameters corresponding to at least one antenna probe. A user,typically a surgeon, may then use the user interface to graphically viewvarious probe parameters stored within the database, and thereby choosean appropriate instrument (e.g., ablation probe) with which to perform asurgical procedure. In an embodiment, a shape selection user interfaceelement is provided to receive a shape selection input, which mayreflect the surgeon's choice of instrument. In an embodiment, anidentifier within the selected probe is recognized by the generatorassembly to confirm the actual probe used by the surgeon corresponds tothe selected probe.

In some embodiments, a three-dimensional view of a probe and an ablationpattern corresponding thereto is displayed on the user interface. Arotation user interface element may be provided by the user interface,wherein rotation the user interface element is configured to accept aninput which causes the user interface to rotate the displayed threedimensional view. In some embodiments, a temporal user interface elementis provided by the user interface that is configured to accept atemporal user input which, in response thereto, causes the graphicaldisplay to present an animation representative of a change in a probeparameter with respect to time.

Also provided is a method for computer-assisted surgical instrumentselection, comprised of providing a selectively-activatable source ofelectromagnetic surgical energy that includes a user interface, andproviding a database in operable communication with the source ofelectromagnetic energy. The database is populated with at least onesurgical instrument parameter and at least one identification parameterassociated with a surgical instrument. A visual representation isgenerated of at least one instrument parameter and displayed on the userinterface. At least one associated identification parameter associatedwith a surgical instrument (e.g., a model number or a clinicaldesignation) may also be displayed. A surgeon responds to the visualdisplay by selecting, with the user interface, a desired surgicalinstrument. The surgeon activates the source of electromagnetic surgicalenergy to supply electromagnetic surgical energy to the selectedsurgical instrument. A surgeon may view a plurality of probe imagesprior to making a selection.

Also disclosed is a computer-readable medium storing a set ofprogrammable instructions configured for being executed by at least oneprocessor for performing a method for computer-assisted surgicalinstrument selection as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features, and advantages of the presentdisclosure will become more apparent in light of the following detaileddescription when taken in conjunction with the accompanying drawings inwhich:

FIG. 1 shows a diagram of a microwave ablation system having a microwaveantenna assembly in accordance with the present disclosure;

FIG. 2 shows a diagram of a microwave ablation system that includes auser interface for displaying and controlling ablation patterns inaccordance with the present disclosure;

FIG. 3 is a block diagram of a microwave ablation system in accordancewith the present disclosure;

FIG. 4A shows a user interface in accordance with the present disclosurewherein a side view of a first ablation pattern is displayed;

FIG. 4B shows a user interface in accordance with the present disclosurewherein a side view of a second ablation pattern is displayed;

FIG. 4C shows a user interface in accordance with the present disclosurewherein an oblique view of a second ablation pattern is displayed;

FIG. 4D shows a user interface in accordance with the present disclosurewherein an axial view of a second ablation pattern is displayed;

FIG. 5A is a graph in accordance with the present disclosureillustrating a relationship between an ablation diameter, time, andpower with respect to a 12 gauge, 915 mHz choked wet tip dipole ablationprobe;

FIG. 5B is a graph in accordance with the present disclosureillustrating a relationship between an ablation shape, time, and powerwith respect to a 12 gauge, 915 mHz choked wet tip dipole ablationprobe;

FIG. 6A is a graph in accordance with the present disclosureillustrating a relationship between an ablation diameter, time, andpower with respect to a 12 gauge, 2450 mHz choked wet tip dipoleablation probe;

FIG. 6B is a graph in accordance with the present disclosureillustrating a relationship between an ablation shape, time, and powerwith respect to a 12 gauge, 2450 mHz choked wet tip dipole ablationprobe;

FIG. 7A is a graph in accordance with the present disclosureillustrating a relationship between an ablation diameter, time, andpower with respect to a 14 gauge, 915 mHz choked wet tip dipole ablationprobe;

FIG. 7B is a graph in accordance with the present disclosureillustrating a relationship between an ablation shape, time, and powerwith respect to a 14 gauge, 915 mHz choked wet tip dipole ablationprobe;

FIG. 8A is a graph in accordance with the present disclosureillustrating a relationship between an ablation diameter, time, andpower with respect to a 14 gauge, 2450 mHz choked wet tip dipoleablation probe; and

FIG. 8B is a graph in accordance with the present disclosureillustrating a relationship between an ablation shape, time, and powerwith respect to a 14 gauge, 2450 mHz choked wet tip dipole ablationprobe.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure will be describedhereinbelow with reference to the accompanying drawings; however, it isto be understood that the disclosed embodiments are merely exemplary ofthe disclosure, which may be embodied in various forms. Well-knownfunctions or constructions are not described in detail to avoidobscuring the present disclosure in unnecessary detail. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a basis for the claims and asa representative basis for teaching one skilled in the art to variouslyemploy the present disclosure in virtually any appropriately detailedstructure.

In the drawings and in the descriptions that follow, the term“proximal,” as is traditional, shall refer to the end of the instrumentthat is closer to the user, while the term “distal” shall refer to theend that is farther from the user.

FIG. 1 shows an embodiment of a microwave ablation system 100 inaccordance with the present disclosure. The microwave ablation system100 includes a microwave antenna probe 112 connected by a cable 115 toconnector 116, which may further operably connect the antenna probe 112to a generator assembly 200 configured to provide, e.g., microwave or RFenergy in a range of about 915 mHz to about 2450 mHz. Antenna probe 112,as shown, is a dipole microwave antenna assembly, but other antennaassemblies, e.g., choked, wet-tip, monopole or leaky wave antennaassemblies, may also utilize the principles set forth herein.

In greater detail, FIG. 2 illustrates a microwave ablation system 100 inaccordance with the present disclosure. The disclosed system includes anactuator 120, which may be a footswitch, a handswitch, a bite-activatedswitch, or any other suitable actuator. Actuator 120 is operably coupledby a cable 122 via connector 118 to generator assembly 200. Cable 122may include one or more electrical conductors for conveying an actuationsignal from actuator 120 to generator assembly 200. In an embodiment,actuator 120 is operably coupled to generator assembly 200 by a wirelesslink, such as without limitation, a radiofrequency or infrared link. Atleast one additional or alternative microwave antenna probe 112′ may beincluded with microwave ablation system 100 that may havecharacteristics distinct from that of microwave antenna probe 112. Forexample without limitation, microwave antenna probe 112 may be a 12gauge probe suitable for use with energy of about 915 mHz, whilemicrowave antenna probe 112′ may be a 14 gauge probe suitable for usewith energy of about 915 mHz. Other probe variations are contemplatedwithin the scope of the present disclosure, for example withoutlimitation, a 12 gauge operable at 2450 mHz, and a 14 gauge operable at2450 mHz. In use, the user, typically a surgeon, may interact with userinterface 205 to preview operational characteristics of available probes112, 112′ et seq., and to choose a probe for use in accordance withsurgical requirements.

Generator assembly 200 includes a generator module 286 in operablecommunication with processor 282 that is configured as a source of RFand/or microwave energy. In an embodiment, generator module 286 isconfigured to provide energy of about 915 mHz. Generator module 286 mayalso be configured to provide energy of about 2450 mHz (2.45 gHz.) Thepresent disclosure contemplates embodiments wherein generator module 286is configure to generate a frequency other than about 915 mHz or about2450 mHz, and embodiments wherein generator module is configured togenerate variable frequency energy. Probe 112 is operably coupled to anenergy output of generator module 286.

Actuator 120 is operably coupled to processor 282 via user interface210. In embodiments, actuator 120 may be operably coupled to processor,and/or to generator 286 by a cable connection, or a wireless connection.

Generator assembly 200 also includes user interface 205, that mayinclude a display 210 such as, without limitation, a flat panel graphicLCD display, adapted to visually display at least one user interfaceelement 230, 240. In an embodiment, display 210 includes touchscreencapability (not explicitly shown), e.g., the ability to receive inputfrom an object in physical contact with the display, such as withoutlimitation a stylus or a user's fingertip, as will be familiar to theskilled practitioner. A user interface element 230, 240 may have acorresponding active region, such that, by touching the screen withinthe active region associated with the user interface element, an inputassociated with the user interface element is received by the userinterface 205.

User interface 205 may additionally or alternatively include one or morecontrols 220, that may include without limitation a switch (e.g.,pushbutton switch, toggle switch, slide switch) and/or a continuousactuator (e.g., rotary or linear potentiometer, rotary or linearencoder.) In an embodiment, a control 220 has a dedicated function,e.g., display contrast, power on/off, and the like. Control 220 may alsohave a function which may vary in accordance with an operational mode ofthe ablation system 100. A user interface element 230 may be positionedsubstantially adjacently to control 220 to indicate the functionthereof. Control 220 may also include an indicator, such as anilluminated indicator (e.g., a single- or variably-colored LEDindicator.)

Turning now to FIG. 3, generator assembly 200 includes a processor 282that is operably coupled to user interface 210. A storage device 288 isoperably coupled to processor 282, and may include random-access memory(RAM), read-only memory (ROM), and/or non-volatile memory (NV-RAM,Flash, and disc-based storage.) Storage device 288 may include a set ofprogram instructions executable on processor 282 for executing a methodfor displaying and controlling ablation patterns in accordance with thepresent disclosure. Generator assembly 200 may include a data interface290 that is configure to provide a communications link to an externaldevice 291. In an embodiment, data interface 290 may be any of a USBinterface, a memory card slot (e.g., SD slot), and/or a networkinterface (e.g., 100BaseT Ethernet interface or an 802.11 “WiFi”interface.) External device 291 may be any of a USB device (e.g., amemory stick), a memory card (e.g., an SD card), and/or anetwork-connected device (e.g., computer or server.) Generator assembly200 may also include a database 284 that is configured to store andretrieve probe data, e.g., parameters associated with one or more probes112. Parameters stored in database 284 in connection with a probe mayinclude, but are not limited to, probe identifier, a probe diameter, afrequency, an ablation length, an ablation diameter, a temporalcoefficient, a shape metric, and/or a frequency metric. In anembodiment, ablation pattern topology may be included in database 284,e.g., a wireframe model of a probe 112 and/or an ablation patternassociated therewith.

Database 284 may also be maintained at least in part by data provided byexternal device 291 via data interface 290. For example withoutlimitation, probe data may be uploaded from an external device 291 todatabase 284 via data interface 290. Additionally or alternatively,probe data may be manipulated, e.g., added, modified, or deleted, inaccordance with data and/or instructions stored on external device 291.In an embodiment, the set of probe data represented in database 284 isautomatically synchronized with corresponding data contained in externaldevice 291 in response to external device 291 being coupled (e.g.,physical coupling and/or logical coupling) to data interface 290.

Processor 282 is programmed to enable a user, via user interface 205and/or display 210, to view at least one ablation pattern and/or otherprobe data corresponding to a probe 112 et seq. For example, a surgeonmay determine that a substantially spherical ablation pattern isnecessary. The surgeon may activate a “select ablation shape” mode ofoperation for generator assembly 200, preview a number of probes byreviewing graphically and textually presented data on display 210,optionally or alternatively manipulate a graphic image by, for example,rotating the image, and to select an appropriate probe 112 et seq. basedupon displayed parameters. The selected probe may then be coupled togenerator assembly 200 for use therewith. In an embodiment, probe 112may include an identifier (not explicitly shown) that provides anidentification signal to generator assembly 200 to facilitateconfirmation that a particular probe 112 of the selected type is coupledto generator assembly 200.

In an embodiment, a surgeon may input via user interface 205 a probeparameter to cause generator assembly 200 to present at least one probecorresponding thereto. For example, a surgeon may require a 3.0 cmdiameter ablation pattern, and provide an input corresponding thereto.In response, the generator assembly 200 may preview a correspondingsubset of available probes that match or correlate to the inputtedparameter.

Turning now to FIGS. 4A-4D, generator assembly 200 provides a userinterface 210 which may present a probe image 302. Probe image 302 maybe a three dimensional (e.g., 3D) graphic rendering of thecharacteristics of probe 112 that are stored in database 284. Probeimage 302 may be rendered using any suitable rendering technique, suchas wire-frame projections and/or ray-tracing. User interface 210provides a select ablation shape indicator 303, which may be a graphicicon or a textual command, that informs the user that generator assembly200 is in a probe selection mode (e.g., probe select and/or ablationshape selection mode). A shape selection user interface element 305, 306may be provided for receiving a shape selection user input therebyenabling a user to choose an ablation shape from among one of a set ofablation shapes and/or probes stored in database 282. A probedesignation 301 (e.g., probe name) may be displayed. As seen in FIG. 4A,a shape selection user interface element 305, 306 may include a graphicicon, such as without limitation, an arrowhead, and/or may includetextual commands, such as “previous” or “next.”

Additional parameters 307 of one or more displayed probes 112 may bepresented on display 210, which may include probe diameter, frequency,ablation length, ablation diameter, and/or shape metric. A shape metricis defined as a minimum ablation diameter expressed as a percentage of amaximum ablation diameter, e.g., 100(d_(min)/d_(max)), where d_(min) isa minimum ablation diameter and d_(max) is a maximum ablation diameter.

By actuating a shape selection icon, a user may cause display 210 todepict characteristics of a different probe 112 as stored in database282. For example, as shown in FIG. 4B, a user has made a shape selectionby activating a shape selection user interface element 305, 306, causingan characteristics of an alternative probe 302′ to be displayed. Thecorresponding user interface elements are updated accordingly, suchthat, as seen in FIG. 4B, the corresponding probe designation 301′,probe image 302′; and additional parameters 307′ correctly reflectcharacteristics of the currently-displayed probe.

As shown in FIGS. 4C and 4D, the user may activate a rotate ablationimage mode of display for generator assembly 200 wherein a rotation userinterface element 312, 314 may be used to display alternate probe imageviews 302″, 302″′ in response to receiving a rotation user input. In anembodiment, rotation user interface element 312, 314 may be a hiddenand/or invisible region of display 210, permitting the user to cause theprobe image 302′ to be rotated by, for example, wiping a fingertip onthe display 210 (e.g., gesturing) to indicate the direction and axis ofrotation. Rotation user interface element 312, 314 may be visible andinclude arrowheads 311, 313, 315, 316 to denote upward rotation,downward rotation, left rotation, and right rotation, respectively, ofprobe image 302′.

In an embodiment, at least one patient image, e.g., ultrasound, CT scan,MRI, and the like, (not explicitly shown) may be presented on display210 over which a displayed probe 302 is superimposed thereupon to enablethe user to visualize an ablation pattern of a probe 302 in situ withsurrounding tissue. The patient image may be a 3D image and responsiveto an input received by rotation user interface element 312, 314, suchthat the patient image and displayed probe 302 rotate together in asubstantially synchronized manner to enable a user to visualize therelationship of the probe 302, ablation pattern thereof and surroundingtissue from a plurality of viewing angles.

A temporal user interface element (not explicitly shown) may be providedto enable a user to view changes in an ablation pattern over time.Temporal user interface element may include, for example, a slider,which may be positioned at a desired point along a time scale to view anablation pattern corresponding thereto. In an embodiment, actuation of atemporal user interface element may cause an animated depiction of anablation pattern to be displayed. Such animation may be displayed inreal-time, slower than real-time, or faster than real-time.

A user may confirm a probe choice by activating an accept selection userinterface element 308, or exit a probe selection mode without making aselection by activating a cancel selection user interface element 309.

Turning now to FIGS. 5A, 5B, 6A, 6C, 7A, 7D, 8A, and 8B, examples ofmeasures minimum ablation diameter and shape metric are shown withrespect to probe diameter and operating frequency. FIG. 5A illustrates arelationship between an ablation diameter, time, and power of a 12 gaugediameter, 915 mHz choked wet tip dipole ablation probe. FIG. 5B is agraph illustrating a relationship between an ablation shape, time, andpower of a 12 gauge, 915 mHz choked wet tip dipole ablation probe. FIG.6A illustrates a relationship between an ablation diameter, time, andpower of a 12 gauge diameter, 2450 mHz choked wet tip dipole ablationprobe. FIG. 6B is a graph illustrating a relationship between anablation shape, time, and power of a 12 gauge, 2450 mHz choked wet tipdipole ablation probe. FIG. 7A illustrates a relationship between anablation diameter, time, and power with respect to a 14 gauge, 915 mHzchoked wet tip dipole ablation probe. FIG. 7B is a graph illustrating arelationship between an ablation shape, time, and power with respect toa 14 gauge, 915 mHz choked wet tip dipole ablation probe. FIG. 8Adepicts a relationship between an ablation diameter, time, and powerwith respect to a 14 gauge, 2450 mHz choked wet tip dipole ablationprobe. FIG. 8B shows a relationship between an ablation shape, time, andpower with respect to a 14 gauge, 2450 mHz choked wet tip dipoleablation probe.

While several embodiments of the disclosure have been shown in thedrawings and/or discussed herein, it is not intended that the disclosurebe limited thereto, as it is intended that the disclosure be as broad inscope as the art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

1-20. (canceled)
 21. An ablation generator comprising: a generatormodule configured to couple to at least one of a plurality of ablationprobes, the generator module configured to generate ablative energy; adisplay configured to display a user interface, the user interfaceconfigured to receive a user-selectable ablation shape and at least oneprobe parameter; and a processor configured to: select at least one ofthe plurality of ablation probes suitable for forming an ablation volumecorresponding to the user-selectable ablation shape based on the atleast one probe parameter; and signal the display to preview at leastone selected ablation probe.
 22. The generator according to claim 21,further comprising: a storage device coupled to the processor andconfigured to store a database of a plurality of probe parameters. 23.The generator according to claim 22, further comprising: a datainterface coupled to the storage device, the data interface configuredto couple to an external device storing an updated plurality of probeparameters.
 24. The generator according to claim 23, wherein the datainterface is further configured to synchronize the database with theupdated plurality of probe parameters.
 25. The generator according toclaim 21, wherein the at least one probe parameter is selected from thegroup consisting of a probe diameter, a frequency, an ablationdimension, and a temporal coefficient.
 26. The generator according toclaim 22, wherein the user interface includes a rotation user interfaceelement configured to rotate the user-selectable ablation shape.
 27. Thegenerator according to claim 21, wherein the user interface includes atemporal user interface element configured to display an animateddepiction of the user-selectable ablation shape.
 28. The generatoraccording to claim 27, wherein the temporal user interface elementincludes a user-adjustable slider corresponding to a time scale of theanimated depiction.
 29. A method for planning an ablation procedure, themethod comprising: displaying a user interface configured to receive auser-selectable ablation shape and at least one probe parameter;selecting at least one of a plurality of ablation probes suitable forforming an ablation volume corresponding to the user-selectable ablationshape based on the at least one probe parameter; and displaying apreview of the at least one selected ablation probe.
 30. The methodaccording to claim 29, further comprising: storing a database of aplurality of probe parameters in a storage device.
 31. The methodaccording to claim 30, further comprising: coupling an external devicestoring an updated plurality of probe parameters to a data interfacecoupled to the storage device.
 32. The method according to claim 31,wherein coupling the external device further includes automaticallysynchronizing the database with the updated plurality of probeparameters.
 33. The method according to claim 29, wherein the at leaston probe parameter is selected from the group consisting of a probediameter, a frequency, an ablation dimension, and a temporalcoefficient.
 34. The method according to claim 29, wherein displayingthe user interface further includes displaying a rotation user interfaceelement configured to rotate the user-selectable ablation shape.
 35. Themethod according to claim 29, wherein displaying the user interfacefurther includes displaying a temporal user interface element configuredto display an animated depiction of the user-selectable ablation shape.36. The method according to claim 35, wherein displaying the temporaluser interface element further includes displaying a user-adjustableslider corresponding to a time scale of the animated depiction.